A prospective, multicenter, randomized, three-arm, parallel-controlled clinical study of the efficacy and safety of an electrocooled ablation system for the treatment of lung tumors

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Test group:Standard treatment plus electrocooling ablation system;Standard treatment group:Standard treatment of lung tumors (clinical guidelines for the treatment of primary lung cancer and metastatic lung cancer);Control group:Standard treatment plus cryosurgery system; CONDITION: Lung tumors (primary lung cancer and metastatic lung cancer) PRIMARY OUTCOME: Efficiency at 3 months after tumor ablation; SECONDARY OUTCOME: Efficiency at 1,3, 6 and 12 months after ablation;Immediate efficacy after ablation;Changes in CT values after ablation;Disease control rates at 1, 3, 6, and 12 months after ablation;Local recurrence rates at 1, 3, 6, and 12 months after ablation;Serum tumor marker test: CEA, CYFRA21‐1, SCC;ECOG Rating;Overall survival rate at 1 year after surgery; INCLUSION CRITERIA: 1) Age 18 to 85 years old (including 18 and 85 years old), both sexes; 2) Patients with clearly diagnosed primary lung cancer or metastatic lung cancer, with the number of unilateral lung lesions = 3, target lesions measurable, 1 cm < target lesion < 6 cm, requiring ablative surgical treatment; 3) Those who cannot tolerate surgical resection or refuse it; 4) ECOG physical status score 0 2; 5) Voluntary participation with the free will of the subject or legal representative, and signed informed consent form.
Epistemonikos ID: 75d8e2721d183f60b75fa7bac8103a86ab648b6a
First added on: Feb 20, 2024